Surgical staple

ABSTRACT

A generally U-shaped surgical staple comprises a base  10  and a pair of generally “L”-shaped legs  12  extending substantially perpendicularly from opposite ends of the base respectively. The legs  12  in use of the staple are bent through approximately 90° relative to the base. To effect a greater compression of the stapled tissue the legs include a penetrative portion  16  adjacent the tip and a compressive structure  30  which, due to its increased height relative to that of the penetrative portion, spreads the compressive forces of the staple further along the length of the incision being closed. The compressive portion also provides a depth stop to avoid the tip penetrating too deeply into the tissue in which it is deployed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/240,183 filed on Jan. 22, 2003 and entitled “Surgical Staple” (nowU.S. Pat. No. 7,108,709), which is a continuation of InternationalApplication PCT/IE02/00078, filed on Jun. 4, 2002, entitled “SurgicalStaple,” which claims priority to Irish Application No. S2001/0547,filed on Jun. 7, 2001. The complete disclosures of these applicationsare hereby incorporated herein by reference for all purposes.

FIELD OF THE INVENTION

This invention relates to a surgical staple.

BACKGROUND OF THE INVENTION

Staples have been used in general surgery for many years, mainly foranastomosing tissue. Examples include skin staplers used to close a skinincision in place of the standard manual suturing process, andend-to-end and end-to-side bowel stapling instruments which aregenerally one shot devices used during bowel reconstruction procedures.

The staples used with these devices are generally manufactured from ametal or metal alloy material such as stainless steel or titanium. Themajority are constructed from round profile wire and generally producedin a generally ‘U’-shaped configuration. The ends of the ‘U’-shape arenormally pointed or sharpened so as to ensure easy tissue penetration.Examples of prior art in this area include U.S. Pat. Nos. 4,505,273,5,026,390 and 4,719,917.

In clinical use the staples are delivered using a stapler device whichgenerally consists of an anvil component positioned inside the ‘U’between staple legs and in contact with the staple. A former componentis positioned on the other side of the staple base, the gap between theforming arms of the former being approximately the width of the anvilplus two times the diameter of the staple wire. The head of the staplerdevice is normally positioned centrally across the slit or opening whichis to be closed.

On activation of the device the staple legs are advanced forward so thatthey penetrate the tissue on both sides of the slit or opening. As theformer is advanced further the legs of the staple bend around the anvilcausing the tips of the legs to advance along an arcuate path towardeach other so that the staple ultimately assumes a generally rectangularshape thereby compressing the tissue which has been trapped between thestaple legs. This compression of tissue is the mechanism by which aclosure is effected. Depending on the length of the incision or openinga series of staples will be delivered along its length in order toensure a blood tight closure.

While this method of closing an incision is effective when a series ofstaples are used along the length of the incision it is less effectivewhen it is desirable to close the opening with the minimum number ofstaples. For example for an incision of 5-6 mm in length one round wirestaple positioned centrally along the incision is insufficient to effecta closure as the compression due to the staple legs only acts in alimited area towards the center of the incision, leaving the extremitiesopen.

Also in situations where the tissue is soft and friable the narrowstaple leg will have a tendency to tear through the tissue as they arebent around the anvil thereby decreasing the level of compressionbetween the staple legs and causing unnecessary damage to the vesselwall.

In order to avoid complications such as clot formation, it is importantto retain the staple legs within the vessel wall, i.e. avoid thepenetration of the internal wall on the introduction of a foreign bodyinto the lumen of the vessel. If the staple legs penetrate into thelumen of the vessel there is the added danger that excessive pressurefrom the staple gun may cause the vessel to collapse, which can lead tothe legs penetrating the opposing vessel wall, i.e. stapling the vesselwalls together and blocking the lumen of the vessel.

Therefore there is a need for an improved surgical staple which willmore effectively close an incision, thereby requiring fewer staples toclose an incision. In addition it would be advantageous to profile thestaple legs so that they are less inclined to tear through softertissue. Furthermore, it would be desirable to limit the depth ofpenetration of the staple legs to prevent the legs entering the lumen ofthe vessel.

SUMMARY OF THE INVENTION

Accordingly, the present invention provides a surgical staple comprisinga base and a pair of legs each extending from an opposite end of thebase, each leg having a penetrative portion terminating at a tip, thestaple being deformable to bend each leg relative to the base causingeach tip to approach the other leg along a substantially arcuate pathlying in a plane, wherein each leg further comprises a compressiveportion located intermediate the base and the penetrative portion, thecompressive portion having a height greater than that of the penetrativeportion, said heights being measured in the direction perpendicular tothe plane defined by the arcuate path.

The advantage of the invention is that the improved surgical stapledelivers a significantly increased area of compression between thestaple legs once the staple has been deformed in use. The increased areaof compression is achieved by providing the compression portion whichtends to increase the contact area between the staple and the tissueagainst which it is bearing.

The invention is particularly useful in applications where the staple ispermanently implanted inside the body. In such cases it is desirable tominimize the amount of metal which is needed to effect a positiveclosure. With existing stapler devices a series of staples need to bepositioned along the length of the slit or tissue edges beinganastomosed. Staples are normally positioned close together as any onestaple will only compress a small amount of tissue on either side. Usingstaples with an improved compression capacity, as provided by thisinvention, will mean that a significantly lower number of staples isrequired to close any one incision.

The invention also has particular relevance in the area of vascularpuncture closure. During this percutaneous procedure it is desirable toclose the arterial puncture preferably with one staple. Again it isdesirable that the staple contains the minimum amount of metal. However,it is important that once delivered the staple has generated enoughcompression along the length of the slit or hole to prevent any bloodleakage. The direction of height of the compression portion normal tothe plane of closure of the legs corresponds in use to the direction oflength along the incision.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described, by way of example,with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a conventional surgical staple.

FIG. 2 a is a sectional view of an unformed staple in a vessel wall.

FIG. 2 b is a sectional view of a partially formed staple in a vesselwall.

FIG. 2 c is a sectional view of a staple fully formed in a vessel wall.

FIG. 3 a is a plan view of a staple before and after forming.

FIG. 3 b is an enlarged view of a staple leg before and after forming.

FIG. 4 is a plan view of a staple in position across a tissue opening.

FIGS. 5 to 9 are perspective views of embodiments of the invention.

FIG. 10 is a plan view of the staple of FIG. 9 in position across atissue opening.

FIGS. 11 and 12, FIGS. 13 and 14, and FIGS. 15 and 16, respectively, arefurther perspective views of three additional embodiments of staple,each shown before and after forming.

In the figures the same reference numerals have been used to indicatethe same or equivalent components.

DETAILED DESCRIPTION OF THE INVENTION

Referring first to FIG. 1, a conventional round wire surgical staple isof a generally ‘U’-shaped configuration, consisting of a base 10 and apair of “L”-shaped legs 12 each having a proximal portion 14 forming alinear extension of the base before use (as shown in FIG. 1) and adistal portion 16 projecting substantially perpendicularly from theproximal portion.

The free ends 18 of the staple legs are generally sharpened so as toensure easy tissue penetration. In addition to penetrating the tissuethe staple is also formed in use, to bring the free ends of the legstogether and thereby hold closed a wound. By forming the staple, thestaple is transformed from a generally “U”-shaped configuration to agenerally rectangular shaped configuration during the delivery process.This occurs by bending the legs 12 through 90° relative to the base 10of the staple at the point where the proximal portions of the legs meetthe base (known as the bend points and denoted as points X and Y in thedrawings) at points relative to the central portion 10 b.

FIGS. 2( a) to 2(c) are a sequence of views showing the process by whichthe conventional staple is deployed and deformed from a generally“U”-shape to a generally rectangular shape to effect a closure of apuncture hole or slit 20 in a vessel or other tissue 22. In FIG. 2 a thestaple has been advanced from the delivery device (not shown) such thatthe distal portions of the staple legs 16 have punctured the tissue 22and the staple base 10 and proximal portions 14 are lying against theouter surface of the tissue. In FIG. 2 b the forming process has begunand the staple is being deformed around bend points X and Y causing theproximal portions 14 and distal portions 16 to arc through an angle ofapproximately 90° thereby compressing the tissue which is being capturedbetween both staple legs. In FIG. 2 c the staple has been fully formedinto a rectangular shape, the tissue contained within the rectanglebeing compressed as a result of the staple legs having arced throughapproximately 90°.

In FIGS. 3 a and 3 b, the staple is shown prior to forming (dashedlines) and after forming (solid lines). As seen particularly in FIG. 3b, it can be seen that prior to forming and following penetration of thestaple leg 12 into the tissue wall that there is an area of tissuecaptive in the region (c). After the forming process, i.e. when proximalportion 14 and distal portion 16 have arced through 90° at the bendpoint Y, the tissue which was previously captive at point (c) has nowmoved to point (d). The same process of compression occurs on theopposite leg of the staple thereby creating compressed tissue 24 (FIG.4) within the rectangular shape of the formed staple.

In FIG. 4, the same compression process can be seen in plan view, thetissue which was captive inside the legs 12 at points (c) prior toforming has been moved to point (d) as a result of the staple formingprocess. However, the level of compression which has transferred to thehole 16 in the tissue is related to the area of surface contact betweenthe staple leg and the tissue at points (c) and (d). With conventionalround wire staples this contact area is quite small and thereforedelivers a limited amount of compression over the length of the holeopening or slit in the tissue. Also, with round wire and leg to cut itsway through softer tissue as opposed to compressing the tissue ahead ofit.

The invention solves this problem by increasing the height of a portionof the legs 12 (i.e. the height being the dimension perpendicular to theplane in which the staple legs bend during forming), in order toincrease the effective contact area between the staple legs and thetissue as the staple is being deformed. Increasing the contact area inthis way will help prevent the staple leg from tearing its way throughthe tissue but more importantly will create a much greater area ofcompression within the rectangle of the formed staple and radiating fromit, so that this compression will be transferred over a much greaterlength of the slit or opening 20 in the tissue.

FIG. 5 is a perspective view of a first embodiment of surgical stapleaccording to the invention. Here the proximal portion 14 of the legs ofthe conventional round wire staple described above have been deformedfrom a round to a flat, rectangular cross-section, providing acompressive portion located between the penetrative portion of the legs(which in this case is the entire proximal portion 16). As mentioned,the purpose of this compressive portion is to increase the surfacecontact area between the staple legs and tissue in the direction inwhich the tissue is being compressed as the staple leg arcs throughapproximately 90° at its bend point.

FIG. 6 shows another embodiment, in which the staple legs have beendivided along the axis of the proximal portions and the oppositedivisions 14′ and 14″ deformed apart so as to significantly increase theoverall height of the proximal portions of the legs.

In FIG. 7 another round wire embodiment of the staple is shown. In thisstaple the wire in the proximal portion 14 of each leg is bentsinusoidally out of alignment with the base 10 to provide a compressiveportion whose height H is significantly greater than the height h of thepenetrative portion of the leg 16, again for the purpose of increasingthe area of compression, and preventing the proximal portion fromentering the wound. In the latter regard, it can be seen that theleading section 28 of the sinusoidally bent proximal portion extendsgenerally at right angles from the penetrative portion 16. This providesa slightly rounded step or shoulder to act as a depth stop, defining theend of the penetrative portion of the leg and the start of thecompressive portion.

FIG. 8 shows an embodiment which consists of a standard round wirestaple with flat plates or wings 30 attached to the proximal portion ofthe legs. FIG. 9 shows another staple similar to that of FIG. 9 which ismanufactured from flat metal stock and bent. Again the staple legsinclude wings 30 such that the height of these wings is significantlygreater than the height of the penetrative portion 16 of the staplelegs.

The process by which these improved staples achieve greater areas ofcompression over the length of an opening in body tissue is illustratedin FIG. 10. FIG. 11 shows a staple of the kind illustrated in FIG. 9 butthe same principle applies to all the staples of FIGS. 5 to 9. It can beseen that as the staple legs move from their open position at ‘A’ totheir closed position at ‘B’ tissue 24 is compressed ahead of the wings30 and this compression radiates over a much greater length of the slitor opening 20 than would be the case if the wings were not attached tothe staple legs.

FIG. 11 shows a staple stamped from a flat sheet and bent into itsinitial configuration (rather than a wire staple as previouslydescribed). The base 10 of the staple is horseshoe shaped rather than aflat linear base. The horseshoe shape defines a “U”-shaped opening 32which allows the staple to sit on top of a blood locator tube extendingfrom the end of a stapler. Such a stapler is described in WO 02/19922.

The stapler of WO 02/19922 takes the form of a hollow shaft and a bloodlocator tube slidable axially within the shaft. The tube projects beyondthe end of the shaft to enter a puncture site in a blood vessel, andblood flowing back through the tube and exiting the device indicates tothe surgeon that the tip of the shaft (where the stapling head islocated) is at the incision in the vessel. A surgical staple straddlesthe tube and is slidable thereon forwardly towards an anvil againstwhich the staple may be deformed to staple together the opposite edgesof the puncture site. A cam mechanism drives the staple forwardly alongthe tube into deforming engagement with the anvil and at the same timeretracts the tube into the shaft in time to allow the legs of the stapleto close onto the puncture site.

The staple of FIG. 11 is adapted for use with such a device in that“U”-shaped opening 32 is adapted to straddle and slide on the bloodlocator tube.

The staple has a pair of legs 12 extending from the ends of the base 10.Each leg is generally “L”-shaped in plan view and comprises a proximalportion 14 and a distal portion 16 terminating at a pointed tip 18. Inuse (see also FIG. 12), the base 10 is held by an anvil (not shown)while forming arms of the stapler (not shown) push the proximal portionsforwardly deforming the staple at bend points X and Y. The blood locatortube is withdrawn during this formation to ensure that as the tips 18approach one another (ultimately coming to rest in the configuration ofFIG. 12), they do not catch the locator tube.

Located on the distal portion 16 is a compressive portion 30 in the formof a bar extending at right angles to the distal portion. In thisstaple, therefore, the compressive portion and the penetrative portionare both located on the distal portion of the “L”-shaped leg. Thepenetrative portion is the part of the leg extending from the bar 30 tothe tip 18. The forward surface 30 a of the bar provides a shoulderacting as a depth stop to prevent the leg penetrating the vessel walltoo deeply. This feature can be used to ensure that the tip will notpenetrate into the lumen of a blood vessel by designing the staple suchthat the distance between the front surface 30 a and the extremity ofthe tip 18 is less than the vessel wall thickness. The bar also servesas a compressive feature spreading the compressive forces provided bythe staple along a length of the incision corresponding to the height Hof the bar 30 (FIG. 12) as opposed to just the lesser height h of thepenetrative portion. The compression is also increased by the relativelysmall distance between the bars 30 when the staple is closed.

By making the staple from a sheet material rather than from wire,another significant advantage is obtainable. The thickness of thematerial of the base (measured between the internal surface of theopening 32 and the corresponding external surface 34) is not constantbut instead increases to a maximum at the apex of the horseshoe. Thisstrengthens the structure against a tendency for the curve to distort asthe staple is being formed. It has been found that the action of theformer and anvil bending the legs relative to the base tends to causethe horseshoe curve to open out or flatten somewhat. It will beappreciated that this can lead to the staple deploying incorrectly, asthe legs tend to deviate from the “straight-ahead” orientation duringclosure. Adding extra material to the curve toward the top selectivelyreinforces the curve at this point of maximum strain during forming andcounteracts the tendency to distort.

Another important feature of the staple of FIGS. 11 and 12 is that thestaple is not symmetrical about the center line. The penetrativeportions 16 are staggered vertically relative to one another so that oneis disposed slightly above the line of the proximal portions and theother slightly below this line.

In addition, the respective tips 18 are beveled oppositely to oneanother so that the leading edge 36 of the tip on the left-handpenetrative portion (as viewed in FIG. 11) is significantly above theleading edge 36 of the right-hand tip. This double offset (staggeringthe respective penetrative portions and reversing the beveling of thetips) allows the two legs to close completely, so that the tips approachone another and pass one another when the staple is formed, providinggreater compression and more reliable closure.

FIGS. 13 and 14 show a further embodiment of staple in open and closedconfigurations. The staple again has a base 10 with a leg 12 extendingfrom each end. The base is horseshoe shaped, but in this case ratherthan there being additional material at the apex of the horseshoe curve,the curve assumes a slight omega (Ω) shape with the ends of the curvepointing inwards to counteract straightening tendencies.

Each leg 12 branches to a pair of tips 18 each having a penetrativeportion 38. The two penetrative portions on each leg extend from theends of a respective compressive portion 30 in the form of a curved barwhich is generally perpendicular to both the proximal portion 14 and thepenetrative portions 38. The bar 30 provides a shoulder acting as adepth stop and acts to spread the compressive forces of the staple alongits length.

It can be seen from FIG. 14 that the legs are once again asymmetricalwith respect to one another. The penetrative portions 38 of theleft-hand leg are both longer and further separated from one anotherthan those of the right-hand leg. Again this ensures that the two legsdo not interfere with one another during closure and that the staple canform a fully closed structure when viewed in plan (see by comparisonFIG. 2C in which there is a gap between the respective tips of the priorart staple, and the curve appears open in plan as a consequence.

The reason for the curvature of the bars 30 in the embodiment of FIGS.13 and 14 is that the stapler for which it is designed has a roundprofile. In general it is desired to make the cross-sectional area ofthe stapler shaft as small as possible to minimize trauma arising fromthe introduction of the stapler. The shape of this embodiment of stapletherefore allows the staple to fit in a rounded shaft while allowing thecompressive portions (bars 30) to grip the sides of the wound as widelyas possible, as will be appreciated with reference to FIG. 10.

FIGS. 15 and 16 provide yet another embodiment in which the penetrativeportions 38 of the legs 12 extend between the tip 18 and a shoulder of acompressive portion of the leg which in this case is provided by a disk40 mounted on the distal portion of each leg.

The embodiments described herein have “L”-shaped legs with a roughly 90°angle between proximal and distal sections. It will be noted that thecompressive section can be on either the proximal section or the distalsection. Furthermore, the legs need not take this “L”-shape and caninstead be curved (e.g. in a quarter-circle), with the portion of legadjacent the tip defining a penetrative portion and a compressivestructure being located further along the curve towards the base.

To aid in staple formation the point at which the legs join the base canbe weakened or provided by a notch, but in most cases this isunnecessary as the deformation between the anvil and former will causethe legs to bend correctly at the junction with the base.

The invention is not limited to the embodiments described herein whichmay be modified or varied without departing from the scope of theinvention.

1-18. (canceled)
 19. A surgical staple comprising: a base; and a pair oflegs each extending from an opposite end of the base, each legcomprising: a proximal portion extending from the base at a bend point;a distal portion extending from the proximal portion at an angle ofbetween 70 and 110 degrees, the proximal portion and the distal portionlying substantially within a plane, the distal portion including apenetrative portion terminating at a tip, the staple being deformable atthe bend point on each leg to bend each leg relative to the base causingeach tip to approach the other tip along a substantially arcuate pathlying in the plane; and a compressive portion located between the baseand the penetrative portion, the compressive portion having a heightgreater than that of the penetrative portion, the heights being measuredin a first direction perpendicular to the plane.
 20. The surgical stapleof claim 19, wherein the compressive portion is disposed on the proximalportion.
 21. The surgical staple of claim 19, wherein the compressiveportion is disposed on the distal portion.
 22. The surgical staple ofclaim 19, wherein the angle between the proximal and distal portions ofeach leg is approximately 90 degrees.
 23. The surgical staple of claim19, wherein the penetrative portions are substantially round incross-section and the compressive portions are substantially flat incross-section, the flat surfaces of the compressive portions extendingin the first direction.
 24. The surgical staple of claim 23, wherein thestaple is formed from a length of substantially round wire and thecompressive portions are formed by flattening a length of the wireforming part of each leg.
 25. The surgical staple of claim 23, whereinthe staple is formed from a length of substantially round wire and thecompressive portions comprise plates attached to the round wire.
 26. Thesurgical staple of claim 19, wherein the compressive portions comprisesections of elongate material bent out of alignment with the penetrativeportions in the first direction.
 27. The surgical staple of claim 26,wherein the bent sections are sinusoidal.
 28. The surgical staple ofclaim 19, wherein a portion of each leg is divided and the dividedportions of the leg are bent away from each other in the first directionto form the compressive portions.
 29. The surgical staple of claim 19,wherein the legs and the base are integrally formed of a unitaryconstruction from the same piece of material.
 30. A surgical staplecomprising: a base; and a pair of legs each extending from an oppositeend of the base, the legs and the base being integrally formed of aunitary construction from the same piece of material, each legcomprising: a penetrative portion terminating at a tip, the staple beingdeformable at a bend point on each leg to bend each leg relative to thebase causing each tip to approach the other leg along a substantiallyarcuate path lying in a plane; and a compressive portion located betweenthe base and the penetrative portion, the compressive portion having aheight greater than that of the penetrative portion, the heights beingmeasured in a first direction perpendicular to the plane defined by thearcuate path.
 31. The surgical staple of claim 30, wherein thecompressive portion is formed on the proximal portion.
 32. The surgicalstaple of claim 30, wherein the compressive portion is formed on thedistal portion.
 33. The surgical staple of claim 30, wherein each legcomprises a proximal portion extending from the base at the bend pointand a distal portion extending from the proximal portion at an angle ofbetween 70 and 110 degrees, the proximal portion and the distal portionlying substantially within the plane.
 34. The surgical staple of claim30, wherein the penetrative portions are substantially round incross-section and the compressive portions are substantially flat incross-section, the flat surfaces of the compressive portions extendingin the first direction.
 35. The surgical staple of claim 34, wherein thestaple is formed from a length of substantially round wire and thecompressive portions are formed by flattening a length of the wireforming part of each leg.
 36. The surgical staple of claim 30, whereinthe staple is a single piece of flat metal stock, cut and bent to formthe staple.
 37. A surgical staple comprising: a base; and a pair of legseach extending from an opposite end of the base, each leg comprising: aplurality of penetrative portions, each terminating at a tip, the staplebeing deformable at a bend point on each leg to bend each leg relativeto the base causing each tip to approach the other leg alongsubstantially arcuate paths lying in substantially parallel planes; anda compressive portion located between the base and the penetrativeportions, the compressive portion having a height greater than that ofeach penetrative portion, the heights being measured in a firstdirection perpendicular to the parallel planes defined by the arcuatepaths.
 38. The surgical staple of claim 37, wherein the penetrativeportions of each leg are connected by the compressive portion of theleg.
 39. The surgical staple of claim 37, wherein the staple isdeformable in a manner which allows the tips of one leg to approach andpass the tips of the other leg, each moving in a different butsubstantially parallel plane, when the legs are bent.
 40. The surgicalstaple of claim 37, wherein the staple is deformable in a manner whichallows at least one of the tips of one leg to substantially abut atleast one of the compression portions of the other leg when the legs arebent.
 41. The surgical staple of claim 37, wherein the legs and the baseare integrally formed of a unitary construction from the same piece ofmaterial.
 42. A surgical staple comprising: a base; and a pair of legseach extending from an opposite end of the base, each leg comprising aproximal portion extending from the base at a bend point, and a distalportion extending from the proximal portion at an angle of between 70and 110 degrees, the proximal portion and the distal portion lyingsubstantially within a plane, the distal portion including a penetrativeportion terminating at a tip and the leg including a compressive portionlocated between the base and the penetrative portion, the compressiveportion having a height greater than that of the penetrative portion,the heights being measured in a first direction perpendicular to theplane, the legs bendable between: an open position in which the proximalportions of the legs extend substantially linearly from the base and thetips are spaced apart from each other; and a closed position, in whicheach leg is bent about the corresponding bend point between the leg andthe base such that the proximal portions of the legs are substantiallyorthogonal to the base, the tips are positioned adjacent one another andthe legs lie within the same plane.
 43. The surgical staple of claim 42,wherein in the closed position, the tip of one leg approaches and passesthe tip of the other leg, each moving in a different but substantiallyparallel plane.
 44. The surgical staple of claim 42, wherein in theclosed position, the tip of one leg substantially abuts the compressionportion of the other leg.